On May 4, 2022 PharmaMar (MSE:PHM) reported that it has submitted a conditional marketing authorization application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) (Press release, PharmaMar, MAY 4, 2022, View Source [SID1234613469]). The application is to seek approval for treatment with Zepzelca (lurbinectedin) in adult patients with metastatic Small Cell Lung Cancer (SCLC) who have progressed following prior platinum-based chemotherapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This registration application is based on data from the Phase II basket trial with lurbinectedin, in monotherapy, for the treatment of SCLC. This is the same trial that was used for the conditional approval of lurbinectedin in the US for the same indication and whose results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), ASCO (Free ASCO Whitepaper), meeting in June 2019.

Lurbinectedin received "Accelerated Approval" from the FDA in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression and is already the standard of care in the US. In 2021, lurbinectedin also received marketing authorization in the United Arab Emirates, Canada, Australia and Singapore.

According to regulations, an accelerated authorization requires a confirmatory trial, so PharmaMar announced in December 2021 the start of a confirmatory Phase III clinical trial, LAGOON, evaluating lurbinectedin for the treatment of patients with recurrent SCLC, which will also be used to apply for registration in Europe.